Neuromuscular stimulation cuff

ABSTRACT

The present disclosure describes systems, methods, devices for performing thought-controlled neuromuscular stimulation. Also described are methods for producing a neuromuscular stimulation cuff. The systems and methods generally relate to receiving and processing thought signals indicative of an intended action, and then delivering stimulation to effectuate the intended action through a neuromuscular stimulation cuff. The neuromuscular stimulation cuff includes a flexible printed circuit board having at least one finger and a plurality of electrogel discs disposed on the at least one finger. The neuromuscular stimulation cuff may be produced by providing a layer of polyimide, etching a conductive copper circuit including a plurality of electrodes into the layer of polyimide to form an etched circuit layer, adhering a cover layer onto the etched circuit layer to form a flexible printed circuit board (PCB), and cutting at least one finger from the flexible PCB. The neuromuscular stimulation cuff employs a flexible multi-electrode design which allows for reanimation of complex muscle movements in a patient, including individual finger movement.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 61/733,736, filed on Dec. 5, 2012, and to U.S. ProvisionalPatent Application Ser. No. 61/734,150, filed on Dec. 6, 2012, which areincorporated herein by reference in its entirety.

BACKGROUND

The present disclosure relates to systems, methods, and devices forthought-controlled neuromuscular stimulation. Generally, the system maybe used to receive thought signals indicative of an intended action andprovide electrical stimulation to a damaged or degenerated neuromuscularregion to effectuate the intended action. Methods to produce a flexibleneuromuscular stimulation cuff are also disclosed. The device may be aneuromuscular stimulation cuff which delivers stimulation to restoremovement to parts of the body not under volitional control due todamaged or degenerated neural pathways from spinal cord injury, stroke,nerve damage, motor neural disease, and other conditions or injuries.The system can also be used in a patient that has some local neural ormuscle degeneration for therapeutic or rehabilitation purposes.

Subcutaneous implantable neurostimulation cuffs have been commonly usedto block pain and to restore function to damaged or degenerative neuralpathways. These implantable cuffs are wrapped around a target nerve andgenerally include one or more electrodes arranged to stimulate thenerve. By including more than one electrode and/or a different geometryof electrodes, implantable cuffs such as the flat interface nerveelectrode (FINE) have been able to achieve stimulation selectivity atthe level of individual nerve vesicles.

Transcutaneous neurostimulation cuffs behave similarly to implantablecuffs, however there are important differences. Because the electrodesare placed against the skin, rather than through it, stimulation ispreferably performed on skeletal muscle tissue or muscle groups, ratherthan peripheral nerves located deeper under the skin. Muscularstimulation may be preferable to stimulating major peripheral nerves,e.g. ulnar, median, radial nerves, as stimulating these nerves may causea patient to feel a tingling sensation. By increasing the number andlayout of electrodes in a neuromuscular cuff, similar to the directiontaken with implanted nerve cuff designs, current generationneuromuscular stimulation cuffs have been able to selectively stimulateindividual muscles or muscle groups.

Flexible transcutaneous cuffs have been developed which fit around ahuman appendage such as a forearm to control the wrist or fingers. Theseflexible cuffs may include sensors which record muscle activity, or EMGsignals, and stimulate in response to the EMG signals. Thin filmtechnologies have also become important in the development of functionalelectrostimulation (FES) devices. Devices incorporating thin filmtechnology are often based on a polyimide substrate covered by achromium, gold, or platinum film.

Current neuromuscular cuffs present many limitations, for example, theirinability to receive a stimulation signal which is directly processedfrom thought signals. These neuromuscular cuffs are also not flexiblypositioned over multiple stimulation points. Flexible electrodepositioning is desirable when attempting to restore complex muscularmovements through neuromuscular stimulation. Current neuromuscular cuffsare also incapable of accommodating a wide range of patient appendagegeometries, e.g. varying circumferences, while also staying well adheredto the skin.

An effective wireless system for transmitting human brain signalsdirectly to muscles, and thereby enabling movement throughthought-control, has not yet been developed. Neuromuscular stimulationcuffs for such a system, e.g. which receive an input consisting ofencoded “thought” signals and provide stimulation to muscular regionsaccording to the signals, have also not been developed.

BRIEF DESCRIPTION

The present disclosure relates to systems, methods, and devices forthought-controlled neuromuscular stimulation. Included is aneuromuscular stimulation cuff which receives a thought signalindicative of an intended action, and in response, stimulates a damagedneuromuscular region to effectuate the intended action. Theneuromuscular cuff may include a flexible design, e.g., including aplurality of electrodes arranged on flexible fingers across a singleconductive layer. The flexible fingers allow for variable sizedneuromuscular regions, e.g. paralyzed limbs, to fit within theneuromuscular cuff. The fingers may also allow for increased electrodepositioning choices for reanimation of complex muscle movements. Theneuromuscular cuff may further include an array of electrogel discswhich provide enhanced electrical contact as well as keep cuff adheredto the skin during stimulation-induced movement.

In some embodiments, a system for thought-controlled neuromuscularstimulation includes a sensor for monitoring or recording neural signalsfrom a patient, a neural signal processor for receiving the neuralsignals and processing the neural signals into a re-encoded signal, anda neuromuscular stimulation cuff for delivering stimulation to thepatient according to the re-encoded signal.

In other embodiments, a method for thought-controlled neuromuscularstimulation includes receiving neurological signals from a patientindicative of an intended action, processing neurological signals,generating a re-encoded signal, and delivering neuromuscular stimulationto the patient according to the re-encoded signal to effectuate theintended action.

In yet other embodiments, a device for neuromuscular stimulationincludes a flexible printed circuit board having at least one finger anda plurality of electrogel discs disposed on the at least one finger.

In additional different embodiments, a method for producing aneuromuscular cuff includes providing a layer of polyimide, etching aconductive copper circuit including a plurality of electrodes into thelayer of polyimide to form an etched circuit layer, adhering a coverlayer onto the etched circuit layer to form a flexible printed circuitboard (PCB), and cutting at least one finger from the flexible PCB.

BRIEF DESCRIPTION OF THE DRAWINGS

The following is a brief description of the drawings, which arepresented for the purposes of illustrating the exemplary embodimentsdisclosed herein and not for the purposes of limiting the same.

FIG. 1 is an overview diagram of one embodiment of a system forthought-controlled neuromuscular stimulation.

FIG. 2 is a block diagram for the decoding and re-encoding architectureoperating within the system of FIG. 1.

FIG. 3 is a flow diagram for one embodiment of a method for providingthought-controlled neuromuscular stimulation.

FIG. 4 is a perspective drawing of a neuromuscular stimulation cuffdevice according to an exemplary embodiment, shown in place on a humanarm.

FIG. 5 is a diagram for a concept design for fabricating one embodimentof the neuromuscular stimulation cuff device.

FIG. 6 is a diagram for an etched circuit layer for fabricating oneembodiment of the neuromuscular stimulation cuff device.

FIG. 7 is a close-up view diagram of the etched circuit layer of FIG. 6.

FIG. 8 is an alternative close-up view diagram of the etched circuitlayer of FIG. 6.

FIG. 9 is a diagram for a coverlay layer used in fabricating oneembodiment of the neuromuscular stimulation cuff device.

FIG. 10 is a diagram for a silkscreen layer used in fabricating oneembodiment of the neuromuscular stimulation cuff device.

FIG. 11 is a stack-up diagram used in fabricating one embodiment of theneuromuscular stimulation cuff device.

FIG. 12 is a flow diagram for one embodiment of a method for producing aneuromuscular cuff.

FIG. 13 is an exemplary photograph showing individual finger movementwithin a system for thought-controlled neuromuscular stimulation.

FIG. 14 is an exemplary photograph showing two neuromuscular cuffdevices according to one embodiment disposed on a preparation bench.

FIG. 15 is an exemplary photograph showing two neuromuscular cuffdevices according to the embodiment of FIG. 14.

FIG. 16 is an exemplary photograph showing two neuromuscular cuffdevices according to a different embodiment.

FIG. 17 is an exemplary photograph showing a rigidizer and the primaryside of a neuromuscular cuff device according to yet another embodiment.

FIG. 18 is an exemplary photograph showing the positioning of apatient's arm region over two neuromuscular cuff devices according tothe embodiment of FIG. 14.

FIG. 19 is an exemplary photograph showing two neuromuscular cuffdevices according to the embodiment of FIG. 14 which are wrapped arounda patient's arm region in preparation for neuromuscular stimulation.

FIG. 20 is an exemplary photograph showing two neuromuscular cuffdevices according to the embodiment of FIG. 14 which are alternativelywrapped around a patient's arm region in preparation for neuromuscularstimulation.

DETAILED DESCRIPTION

A more complete understanding of the processes and apparatuses disclosedherein can be obtained by reference to the accompanying drawings. Thesefigures are merely schematic representations based on convenience andthe ease of demonstrating the existing art and/or the presentdevelopment, and are, therefore, not intended to indicate relative sizeand dimensions of the assemblies or components thereof.

Although specific terms are used in the following description for thesake of clarity, these terms are intended to refer only to theparticular structure of the embodiments selected for illustration in thedrawings, and are not intended to define or limit the scope of thedisclosure. In the drawings and the following description below, it isto be understood that like numeric designations refer to components oflike function.

With reference to FIG. 1 and FIG. 2, a system for thought-controlledneuromuscular stimulation may include a cortical implant 102 implantedinto the cerebral cortex region of the brain. The cortical implant 102in one embodiment includes a microelectrode sensing array, as depictedin FIG. 1. The microelectrode sensing array includes multiple channels(e.g. 96 channels) and may be wired to an amplifier which furtheramplifies signals received by the microelectrode array. The corticalimplant 102 records “brain waves,” more particularly neural signalswhich are representative of a varied set of mental activities. Neuralsignals include electrical signals produced by neural activity in thenervous system including action potentials, multi-unit activity, localfield potential, ECoG, and EEG. These neural signals are sent wirelesslyor, alternatively, through a wired connection, from the cortical implant102 to a receiver on a neural signal processor device 104 for processingof the neural signals. In another embodiment, a scalp based interface,headset, or other sensor 102 picks up electroencephalogram (EEG) signalsand sends them to the receiver on the neural signal processor device104.

The neural signal processor 104 may include a processor including neuraldecoding algorithms 106 and/or control algorithms 108. These algorithms106, 108 allow for a received neural signal input to be decoded andsubsequently re-encoded for use in neuromuscular stimulation. Forexample, a received neural signal may be isolated to predict arm and/orhand movements a patient is thinking about. The neural signal processor104 may also include an oscilloscope or other signal waveform viewingand/or manipulation device. The neural signal processor also preferablyincludes an isolated pulse stimulator 111 which receives a processedsignal and generates a pulse signal for use in neuromuscular stimulationby an attached neuromuscular stimulation cuff 110.

With reference to FIG. 2, the system for thought control at a morecomplex architectural level includes the cortical implant or sensor 102and the neural signal processor 104 which allow for the recording ofneural signals and the initial processing of the signals, respectively.Initial signal processing may include analog to digital conversion,normalization, and/or other filtering and processing methods known byone having ordinary skill in the art. Initially processed signals arethen decoded by the neural decoding algorithms 106. In exemplaryembodiments, the neural decoding algorithms 106 include force-basedalgorithms with firing-rate estimators.

The decoded signal output of the neural decoding algorithms 106 isfurther processed by the stimulation control algorithms 108. Inexemplary embodiments, the stimulation control algorithms 108 produce anoutput of peak current amplitude modulated, pulse width modulated, orfrequency modulated pulse trains going to the cuff electrodes. The pulsetrain can also be a non-stationary Poisson type train where averagepulse rate (frequency) is modulated. This may help reduce muscle fatigueas it more closely matches to the body's natural nervous system. Anexample of using poisson-distributed impulse trains to characterizeneurons in a region of the brain is disclosed in Pienkowski et al.,Wiener-Volterra Characterization of Neurons in Primary Auditory CortexUsing Poisson-Distributed Impulse Train Inputs, J. Neurophysiology(March 2009). Stimulation control algorithms 108 may be altered throughinput received from a training profile 107. The training profile 107 mayinclude training profile data representative of past user trainingsessions, e.g. motion demonstrations or coaching periods. Training datamay be used to alter and/or define simulation control algorithms 108during signal processing. Incorporating training data into stimulationcontrol algorithms 108 through a model-based approach yields moreaccurate decoding, e.g. patient thoughts accurately translated into acomplex motion, than prior position-based decoding efforts have shown.Additionally or alternatively, wrist-hand position feedback 109 may beused to alter and/or define stimulation control algorithms 108 duringsignal processing.

Signal control algorithm 108 output may be sent to the isolated pulsegenerator 111, where the signal is converted into a waveform that issuitable for neurostimulation. Suitable waveforms may include monophasicand biphasic pulses with a voltage between 80 to 300 Volts. However,even higher voltages may be used as long as safe current levels aremaintained and proper insulation is used. In exemplary embodiments, thewaveform is a monophasic pulse with a peak current of 0-20 mA which ismodulated to vary strength of muscle contraction, frequency of 50 Hz,and a pulse width duration of 500 ms. The output of the isolated pulsegenerator 111 is sent to the neuromuscular stimulation cuff 110 todeliver functional electrostimulation to the patient.

With reference to the flow diagram set forth in FIG. 3, a method forproviding thought-controlled neuromuscular stimulation S100 starts atS101. At S102 neurological signals are received from a patientindicative of an intended action. For example, neurological signals maybe received though cortical implant 102. At S104 the neurologicalsignals are processed, which may include analog to digital conversion orfiltering. At S106, the digitized signals are decoded by at least oneneural decoding algorithm 106. At S108, the decoded signals areprocessed by at least one stimulation control algorithm 108. At S110,the method alternatively includes altering the stimulation controlalgorithms 108 by training data which is stored in the training profile107. At S112, the method alternatively includes altering the stimulationcontrol algorithms 108 based on movement data, e.g. wrist-hand positionfeedback 109. At S114, the output of the at least one signal controlalgorithm 108 is converted into a re-encoded signal consisting ofmultiple pulse trains, each pulse train going to a correspondingelectrode 114. At S114, neuromuscular stimulation is delivered to thepatient by sending the re-encoded signal to the neuromuscularstimulation cuff 110.

In another embodiment, the method for providing thought-controlledneuromuscular stimulation S100 further includes at S117 deliveringneuromuscular stimulation to the patient by selectively deliveringstimulation to at least one pair of electrodes 114 within aneuromuscular cuff 110 to effectuate the intended action.

In yet another embodiment, the method S100 further includes S103recording neurological signals from a patient. These neurologicalsignals may be sensed from, e.g., a forearm or wrist region with neuralpathway damage. Recording may also occur at a neurologically intactregion such as a functional leg, for which stimulation pulses can beprovided for stimulating commonly tied motions in damaged limbs, e.g.arms and legs. Commonly tied motions include hip and arm movements orpivoting movements. In the same embodiment, method S100 at S118 mayfurther include delivering neuromuscular stimulation to the patient byselectively stimulating to at least one pair of electrodes within theneuromuscular cuff 110 based on the re-encoded signal.

With reference to FIG. 4, an exemplary embodiment of the neuromuscularstimulation cuff 110 includes a flexible printed circuit board (PCB) 112upon which electrodes 114 and hydrogel discs 116 are arranged in anelectrogel disc array 118. The neuromuscular stimulation cuff 110 fitsover a damaged or degenerative neuromuscular region 120, e.g. apatient's arm as illustrated. The flexible PCB 112 may be comprised of asingle layer of flexible polyimide material. Up to approximately twentyelectrodes 114 may be individually etched onto each finger 124 of theflexible PCB 112 as a copper layer. In exemplary embodiments, theflexible PCB 112 has a total of eighty electrodes 114 disposed over fourfingers 124. The electrodes 114 may be subsequently plated with aconductive metal such as gold, palladium, or silver for greaterconductivity.

In some embodiments, electrodes 114 both stimulate a neuromuscularregion 120 by stimulating individual muscles and/or groups of muscles,as well as monitor or record skeletal muscle activity, specificallyelectromyography (EMG) signals. Sensed EMG data pertaining to a sensedmuscle target may be used in methods for closed or open loop stimulationof the muscle target. Sensed EMG data may also be analyzed in decidingwhether to reposition the neuromuscular stimulation cuff 110 within theneuromuscular region 120 or to turn off individual electrodes 114 withinthe electrogel disc array 118.

Hydrogel discs 116 may be rolled over the electrodes 114 to provideenhanced electrical and mechanical coupling. When appropriately aligned,the hydrogel discs 116 completely cover the electrodes 114 andeffectively form conductive electrogel discs 117. Put another way, theelectrodes are located between the base layer and the hydrogel discs.Electrical coupling is enhanced in that hydrogel provides greaterconductive contact with the skin than is achievable with a baremetal-plated electrode surface. Additionally, a carrier signal providedto any of the electrogel discs 117 in the electrogel array 118 mayconduct through the tissues of a patient and be released at any otherelectrogel disc 117 provided in the array 118. Enhanced mechanicalcoupling is provided through the exemplary adherence characteristics ofhydrogel to the skin. Hydrogel discs 116 may stay coupled to the skineven during complex patient movement. The hydrogel discs arecommercially available as a tape which may be rolled on an electrodesurface. One such example includes AmGel 2550 from AmGel Technologies.In the exemplary embodiment of the neuromuscular cuff shown in FIG. 4,the hydrogel discs are provided through custom spaced hydrogel discslocated on AmGel 2550 rolled hydrogel tape.

The electrogel disc array 118 is spread over a plurality of fingers 124,wherein the fingers 124 are cut from the flexible PCB 112 to provideadditional flexibility in the placement of electrogel discs 117.Reanimation of complex motion may require stimulating muscles which arenot located directly along the dimensions of a conventionally shapedneuromuscular cuff 110. By wrapping fingers 124 around differentmuscular regions, e.g. the lower wrist and thumb, complex motions suchas thumb movement may be reanimated more effectively than with limitedplacement options.

FIGS. 5-11 are views of various layers of the neuromuscular stimulationcuff, and are separated for convenience and understanding. Withreference to FIG. 5, one embodiment of the neuromuscular stimulationcuff device 110 may be fabricated in accordance with a concept design500. Dimensions of and between the various components of the conceptdesign 500 are indicated in millimeters (mm). The concept design 500includes, as shown here, a single layer of polyimide base material 522.In some embodiments, the polyimide base material is a DuPont AP8523Epolyimide which is 50 μm (micrometers) thick and rolled-annealed copperclad at 18 μm thick. This base material serves as a substrate for theother layers of the neuromuscular stimulation cuff. The base material522 is cut into four fingers 524, where the electrodes will be located.The fingers can be attached to each other, for example by five webbings525 which run between adjacent fingers. An optional fork 526 ofpolyimide material is located at one end of the fingers. The forkconnects all of the fingers, and is provided for structural support fordesign and mounting. Drilled holes 527 are provided in the fork 526 forsupport and/or mounting purposes. In some embodiments, the four drilledholes 527 are approximately 2.387 mm in diameter with a tolerance of+/0.076 mm. Headers 528 extend from the end of each finger opposite thatof the fork. These headers are thinner than the fingers, and connect thefingers 524 to a rigidizer 530. Though not illustrated, webbings canalso be provided between adjacent headers as well if desired. Therigidizer 530 is an inflexible circuit board used for interfacing withthe neural signal processor 104. Drilled holes 531 are additionallylocated on the rigidizer 530 which represent connector pin insertionpoints. In exemplary embodiments, eighty drilled holes 531 areapproximately 1.016 mm in diameter with a tolerance of +/−0.05 mm.

With reference to FIG. 6, an etched circuit layer 600 for fabricatingthe neuromuscular stimulation cuff device 110 is shown. The etchedcircuit layer 600 is located on the surface of the polyimide substrate622, upon which copper electrodes 640 and connective copper traces 642are etched. The electrodes 640 and traces 642 run along the four fingers624 of the substrate 622. The traces 642 run longitudinally down thefour headers 628 to electrically connect the electrodes 642 to therigidizer 630. The rigidizer 630 is an inflexible circuit board used forinterfacing with the neural signal processor 104. The traces 642continue onto rigidizer 630 and end, in this exemplary embodiment, ateighty connective points 632, which represents twenty connective points632 per finger 624. Each of the eighty connective points 632 correspondsto an individual electrode 640, electrically connected through anindividual trace 642.

FIG. 7 is a closer view of the etched circuit layer 600 of FIG. 6. Thesubstrate 622, electrodes 640, and traces 642 are more particularly seenhere. Each electrode 640 is individually connected to a single trace642, and the trace 642 runs down header 628 to the rigidizer 630 (notshown). In some embodiments, the traces 642 are approximately 0.127 mmin width. As illustrated here, each electrode 640 includes at least oneear 641 which is used to support the electrode 640 upon the substrate622. As seen here, each electrode includes a central area 643 and threeears 641. The central area has a circular shape, and is used as anelectrical contact. Each ear extends beyond the perimeter of the centralarea. As illustrated here, two ears are separated by 60 degrees, and areseparated from the third ear by 150 degrees.

Referring to FIG. 8, the etched circuit layer illustrated in FIG. 6 mayinclude electrodes 640 that are approximately 12 mm in diameter (notcounting the ear) and spaced 15 mm apart. This 15 mm spacing betweenelectrodes would dictate the custom spacing required for subsequentapplication of hydrogel discs 114.

FIG. 9 illustrates a coverlay layer 700 which would be placed over theelectrodes and traces. The coverlay layer can be made from a singlelayer of polyimide 722, which is preferably thinner than the substrateupon which the electrodes and traces are copper-etched. In oneembodiment, the coverlay layer is a DuPont LF0110 polyimide materialwhich is a 25 μm thick coverfilm. A further thickness of 25 μm ofacrylic adhesive can be used for adhering the coverlay layer 700 to theetched circuit layer 600. The coverlay layer includes a fork 726,fingers 724, headers 728, and rigidizer section 730 which corresponds tothese areas on the base substrate 522 and the etched circuit layer 600.Cutouts 740 are left in the fingers to expose the central area of theelectrodes, and on the rigidizer section 730 for the electricalconnectors.

The coverlay layer 700, when applied over the etched circuit layer 600,covers the copper traces 642 etched on the fingers 724 and the headers728. The coverlay layer 700 does not cover the central area 643 of theelectrodes, but does cover the ears 641, thus fixing the electrodes inplace between the substrate and the coverlay layer. In addition, theelectrical connectors in the rigidizer section 730 will remainuncovered. The exposed central area of the electrodes 640 are preferablyplated with a conductive metal such as tin, platinum, or gold. In oneembodiment, exposed copper electrodes are plated withelectroless-nickel-immersion-gold (ENIG) at the level of 3-8 ul goldover 100-150 ul nickel.

FIG. 10 is a diagram for a silkscreen layer 800 that can be used infabricating the neuromuscular stimulation cuff device 110. Thesilkscreen layer 800 is applied to the combination of the etched circuitlayer 600 and coverlay layer 700 to identify individual electronicelements. A first silkscreen identification number 850 is provided toeach electrode 840 so that it may be more easily found after visualinspection. In one embodiment, first silkscreen identification numbers850 span from A1-A20 and D1-D20 to represent eighty individualelectrodes 840. A second silkscreen identification number 852 identifiesthe connection ports for a rigidizer 830. In one embodiment, secondsilkscreen identification numbers 852 span from J1-J4. Both first andsecond silkscreen identification numbers 850, 852 are provided on asecondary side of the neuromuscular stimulation cuff 110, or side facingaway from exposed electrodes 740. In an exemplary embodiment, silkscreenidentification numbers 850, 852 are provided by white epoxynonconductive ink.

Referring now to FIG. 11, various embodiments of the neuromuscularstimulation cuff device may be fabricated according to stack-up diagram900. A polyimide base material provides a substrate 950 upon whichvarious components are fixed. A secondary side rigidizer 830 islaminated to a secondary surface of the substrate 950. The etchedcircuit layer 600 is fabricated onto a primary surface of the substrate(opposite the secondary surface), and includes electrodes and traces.The coverlay layer 700 is subsequently adhered to the etched circuitlayer 600 which covers the traces and leaves exposed portions of theelectrodes. The combination of the substrate 950, etched circuit layer600, and coverlay layer 700 is defined as the flexible PCB 912. Primaryrigidizer 730 is stacked upon the coverlay layer to complete theelectrical connection required to interface the flexible PCB with theneural signal processor 104.

With reference to the flow diagram set forth in FIG. 12, one embodimentof a method for producing a neuromuscular cuff S200 starts at S201. AtS202 a single layer of polyimide base material 950 is provided. At S204,an etched circuit layer is fabricated onto the polyimide base material950 by etching a conductive copper circuit into the polyimide. At S206 apolyimide coverlay layer 700 is adhered to the etched circuit layer 600.Adhering the coverlay layer 700 to the etched circuit layer 600completes the formation of the flexible PCB 912. At S208, a plurality offingers 724 may optionally be cut from the flexible PCB 912 to provideadditional contact points for stimulation of muscles or sensing EMGsignals. At S210, finger webbings 725 may optionally be cut from theflexible PCB 912 to separate the fingers 724 and provide additionalflexibility, such as to accommodate limb twisting (such as the forearm)while maintaining contact. At S212, hydrogel may optionally be rolledover fingers 724 to with electrodes create electrogel discs 117. AtS214, a rigidizer 630, 730, 830 is attached to the flexible PCB 912 forinterfacing with the neural signal processor 104. At S216, the flexiblePCB 912 is interfaced with the neural signal processor 104.

With reference to FIG. 13, individual finger movement within a systemfor thought-controlled neuromuscular stimulation 1000 is demonstrated. Aneuromuscular cuff 1010 according to one embodiment is wrapped over adamaged or degenerative neuromuscular region 1020. The neuromuscularcuff 1010 is interfaced with a neurological signal processor 1004through attached rigidizer 1030. The rigidizer is attached to aconnection port 1005 on the neural signal processor 1004. Receivedneurological signals indicative of patient thinking about moving theirfirst two digits has been decoded and re-encoded into pulse trainsignals transmitted to various electrodes on the neuromuscularstimulation cuff 1010. Using a specific number and spacing ofelectrodes/electrogel discs 1014, 1017 in neuromuscular stimulation cuff1010 has allowed for high resolution and non-invasive neuromuscularstimulation which effectuates the intention of the patient.

Electrogel discs 1017 operate in pairs when reanimating motion.Individual digit movement may be effectuated through the operation oftwo to three pairs (4 to 6 units) of electrogel discs 1017 which arestimulating in tandem. Selecting particular pairs of electrogel discs1017 to reanimate motion as indicated by a decoded brain signal isadvantageously performed by the neuromuscular stimulation cuff 1010, aseach electrogel disc 1017 is connected to the neurological signalprocessor 1004 individually along a single traces etched into aconductive layer of flexible polyimide material.

With reference to FIG. 14, two neuromuscular cuff devices 1010 accordingto one embodiment are disposed on a preparation bench 1070. Thepreparation bench 1070 may be used to keep cuff devices 1010 flat androll hydrogel tape across electrodes 1016. Properly adhered hydrogeldiscs 116 (not shown) should fully cover the surface of electrodes 1014.

With reference to FIG. 15, two neuromuscular cuff devices 1010 accordingto the embodiment of FIG. 14 are shown. The cuff devices 1010 eachinclude a fork 1026 for additional support when designing and/or placingthe cuff devices 1010 over a damaged or degenerative neuromuscularregion (not shown).

With reference to FIG. 16, two neuromuscular cuff devices 1100 accordingto a different embodiment are shown. A fork 1126 is provided at one endof each cuff for additional design and/or structural support, similar tothe fork 626 in FIG. 6. Here, a second fork 1127 is also providedlocated along the headers 1128. Put another way, the fingers 1126 arebracketed by a fork on each end. The additional fork 1127 providesadditional support in combination with fork 1126 for situations when theneuromuscular cuff 1110 must be stretched flat across a surface.Additional fork 1127 can also maintains fingers 1124 within the samedamaged or degenerative neuromuscular region 1120 (not shown), whicheffectively concentrates stimulation and prevents flexibility.

With reference to FIG. 17, the primary side of another embodiment of theneuromuscular cuff 1200 is shown. Hydrogel discs 1216 have been appliedto electrodes 1214 (not shown, covered), forming an electrogel discarray 1218. Two of the four fingers 1224 still include the hydrogel tapebefore being separated from hydrogel discs 1216. Electrogel discs 1217are not connected to each other within the array 1218 so that theelectrogel discs 1217 may be independently stimulated.

While not exposed to the air, copper traces 1242 are viewable throughthe polyimide cover layer 700. A secondary side rigidizer 1230 is shownby folding the primary side over at the headers 1228. Connectors 1234 onthe secondary side rigidizer 1230 allow for the neuromuscularstimulation cuff 1200 to be interfaced with the neural signal processor104 (not shown). Each pin 1236 within connector 1234 is electricallyconnected with a single electrogel disc 1217.

With reference to FIG. 18, a patient's arm including damaged ordegenerative neuromuscular region 1020 is placed over two neuromuscularcuff devices 1010 according to the embodiment of FIG. 14. Flexibleheaders 1028 may be used as support while positioning the device 1010under an arm.

With reference to FIG. 19, two neuromuscular cuff devices 1010 in anexemplary embodiment are wrapped around a patient's arm region 1020 inpreparation for neuromuscular stimulation. The two cuff devices 1010together provide 160 separate electrodes for stimulating finger or wristmovements. Fingers 1024 the neuromuscular cuff to fit around the armregion 1020 at points of varying circumference. Hydrogel discs 1016 (notshown) keep both cuffs 1010 adhered to the arm.

With reference to FIG. 20, two neuromuscular cuff devices 1010 accordingto the embodiment of FIG. 14 are alternatively wrapped around apatient's arm region in preparation for neuromuscular stimulation. Onlytwo fingers 1024 of one of the neuromuscular cuff devices 1010 are beingutilized in combination with all fingers 1024 on the other cuff device1010. More or less electrodes can be used, as shown in FIG. 20,depending on the nature of the damage to a patent's neuromuscular region1020 and the type of movement one wishes to reanimate throughneuromuscular stimulation.

The present disclosure has been described with reference to exemplaryembodiments. Obviously, modifications and alterations will occur toothers upon reading and understanding the preceding detaileddescription. It is intended that the present disclosure be construed asincluding all such modifications and alterations insofar as they comewithin the scope of the appended claims or the equivalents thereof.

1. A device for neuromuscular stimulation (110), comprising a flexible printed circuit board (112) including at least one finger (124) and a plurality of electrogel discs (117) disposed on the at least one finger (124).
 2. The device according to claim 1, wherein the flexible printed circuit board (912) includes etched conductive circuit layer (600).
 3. The device according to claim 1, wherein the flexible printed circuit board (912) includes a polyimide base material (950).
 4. The device according to claim 1, wherein the flexible printed circuit board (912) includes a coverlay layer (700).
 5. The device according to claim 1, wherein the flexible printed circuit board (112) includes a plurality of electrogel discs (117) disposed on the at least one finger (124), wherein each electrogel disc is independently connected to a rigidizer (830).
 6. The device according to claim 5, wherein the rigidizer (830) interfaces with a neural processing device (104).
 7. The device according to claim 1, further including a plurality of fingers (124), each finger (124) of the plurality having a plurality of electrogel discs (117).
 8. A system (100) for thought-controlled neuromuscular stimulation, comprising: a sensor (102) for monitoring or recording neural signals from a patient (101); a neural signal processor (104) for receiving neural signals and processing the neural signals into a re-encoded signal; and a neuromuscular stimulation cuff (110) for delivering stimulation to the patient (101) according to the re-encoded signal.
 9. The system according to claim 8, wherein the neural signal processor (104) decodes the neural signals according to a neural decoding algorithm (106).
 10. The system according to claim 8, wherein the neural signal processor (104) re-encodes the neural signals according to a stimulation control algorithm (108).
 11. The system according to claim 8, wherein the stimulation control algorithm (108) is altered by at least one of a training profile (107) and position feedback data (109).
 12. The system according to claim 8, wherein the neural signals are transmitted wirelessly between the sensor (102) and the neural signal processor (104).
 13. The system according to claim 8, wherein the neuromuscular stimulation cuff (110) includes a flexible printed circuit board (112) having a plurality of electrogel discs (117).
 14. The system according to claim 8, wherein the neuromuscular stimulation cuff (110) delivers stimulation capable of reanimating only one finger within a damaged hand region (103).
 15. The system according to claim 13, wherein the neuromuscular stimulation cuff (110) includes at least one finger (124) for variably positioning the plurality of electrogel discs (117).
 16. The system according to claim 13, wherein the neuromuscular stimulation cuff (110) includes a plurality of fingers (124) for variably positioning the plurality of electrogel discs (117).
 17. The system according to claim 13, wherein the plurality of electrogel discs (117) records neural signals from a region of neuromuscular damage (120).
 18. A method (S100) for thought-controlled neuromuscular stimulation, includes: receiving neurological signals from a patient (101) indicative of an intended action; processing the neurological signals; generating a re-encoded signal; and delivering neuromuscular stimulation to the patient (101) according to the re-encoded signal to effectuate the intended action.
 19. The method according to claim 18, wherein the processing neurological signals includes decoding neurological signals with at least one neural decoding algorithm (106).
 20. The method according to claim 18, wherein the processing neurological signals includes processing the neurological signals with at least one stimulation control algorithm (108).
 21. The method according to claim 18, wherein delivering neuromuscular stimulation to the patient (101) further includes altering the position of electrodes (114) within a neuromuscular stimulation cuff (110) to effectuate the intended action.
 22. The method according to claim 18, wherein delivering neuromuscular stimulation to the patient (101) further includes selectively delivering stimulation to at least one pair of electrodes (114) within a neuromuscular stimulation cuff (110) to effectuate the intended action.
 23. The method according to claim 18, further including recording EMG signals from the damaged neuromuscular region (120).
 24. The method according to claim 18, wherein delivering neuromuscular stimulation to the patient (101) further includes selectively delivering stimulation to at least one pair of electrodes (114) within a neuromuscular stimulation cuff (110) based on the re-encoded signal.
 25. A method (S200) for producing a neuromuscular stimulation cuff (110), comprising: providing a substrate layer (950); fabricating a conductive circuit including a plurality of electrodes (114) into the substrate layer (950) to form etched conductive circuit layer (600); adhering a coverlay layer (700) onto the conductive circuit layer (600) to form a flexible printed circuit board (PCB) (912); and cutting at least one finger (124) from the flexible PCB (912).
 26. The method according to claim 25, further including plating the plurality of electrodes (114) with at least one of gold and nickel.
 27. The method according to claim 25, further including coating the plurality of electrodes (114) with hydrogel.
 28. The method according to claim 25, further including rolling hydrogel over the at least one finger (124) to produce an electrogel disc array (118).
 29. The method according to claim 25, further including cutting a plurality of fingers (124) from the flexible PCB (112).
 30. The method according to claim 25, further including cutting a webbing (525) between the plurality of fingers (124) to increase flexibility.
 31. The method according to claim 25, further including laminating a rigidizer (830) to the flexible PCB (112) for interfacing with a neural signal processor (104). 